Shares of Helius Medical Technologies, Inc. (HSDT) soared 37% on Thursday, after the company announced positive clinical results from its PoNS Stroke Registrational Program (SRP).
The stock opened at $13.81, significantly above its prior close of $8.90. Trading volume was over 15.6 million shares, far above average daily volume of 153,000.
The neurotechnology firm focused on neuromodulation-based therapies said the PoNS device, a portable neuromodulation stimulator, demonstrated statistically significant improvements in gait and balance in chronic stroke patients.
The double-blind randomized clinical trial met its primary endpoint, with minimal adverse events reported and strong tolerability observed across treatment groups.
The PoNS system is already designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). The company plans to use the SRP results as the foundation for a forthcoming FDA submission seeking marketing authorization for an expanded indication related to stroke-related gait and balance impairments.
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